Case 4:22-cv-02755 Document 1-3 Filed on 08/15/22 in TXSD Page 1 of 9
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`EXHIBIT C
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`EXHIBIT C
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`2022-38664
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`No.
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`6/28/2022 12:54 PM
`Marilyn Burgess - District Clerk Harris County
`Envelope No. 65843382
`By: Carolina Salgado
`Filed: 6/28/2022 12:54 PM
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`RICKY MARSHALL,
`Plaintiff
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`V.
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`MEDTRONIC, INC.
`Defendant
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`IN THE DISTRICT COURT OF
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`HARRIS COUNTY, TEXAS
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`11 th
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`JUDICIAL DISTRICT
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`PLAINTIFF'S ORIGINAL PETITION
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`TO THE HONORABLE JUDGE OF SAID COURT:
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`COMES NOW, Ricky Marshall, plaintiff, complaining of Medtronic, Inc., defendant, and
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`for cause of action would show as follows:
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`I.
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`This case should be governed in accordance with the Discovery Control Plan found in Rule
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`190 of the Texas Rules of Civil Procedure (Level 3).
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`II.
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`Ricky Marshall ("Marshall'~ is an individual residing in Houston, Harris County, Texas.
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`Medtronic, Inc., a subsidiary of Medtronic PLC ("Medtronic"), is a foreign eorporation with
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`its principle operational offices located at 710 Medtronic Parkway, Minneapolis, Minnesota 55432-
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`5604. Medtronic is and has been doing business in the State of Texas. Medtronic may be served
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`with process through its agent for process, Corporation Service Company d/b/a CSC-Lawyers
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`Incorporating Service Company 211 E. 7th Street, Suite 620, Austin, TX 78701-3136 USA.
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`Marshall seeks to recover damages he has sustained due to a defective LVAD pump system,
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`sometimes referred to as the HeartWare HVAD device ("HeartWare device"), manufactured and
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`sold by Medtronic that was implanted in Marshall's chest by Saram Nathan, M.D. at Memorial
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`Hermann Hospital, Houston, Harris County, Texas, on June 4, 2020. Marshall was discharged from
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`Memorial Hermann Hospital on June 29, 2020. 1Vlarshall underwent this implant surgery due to
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`end-stage heart failure from which he was suffering. He understood at the time of his surgery the
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`HeartWare device would assist his own circulatory system by pumping blood from his damaged
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`heart. The Heartware device would keep Marshall alive until he was approved for and could
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`undergo a heart transplant procedure.
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`~
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`Medtronic abruptly pulled its HeartWare device from the market in late May, 2021, less than
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`a year after the device was implanted in Marshall's chest. The action undertaken by Medtronic came
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`as a result of numerous Class I recalls and reports of patient injuries and deaths associated with the
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`device. Prior to the implant surgery involving Marshall, there was great concern with the Medtronic
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`HeartWare device regarding ongoing failures and a"growing body of observational clinical
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`comparisons indicating a higher frequency of neurological adverse events, including stroke, and
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`mortality with the Heartware device as compared to other circulatory support devices available to
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`patients." At the time Medtronic stopped selling the HeartWare device, approximately 4,000
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`patients had the device impla.nted, including Marshall. Moreover, Medtronic advised against elective
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`explants of the HeartWare device due to potential health risks to the patient. A patient such as
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`Marshall was as likely to die from removal of the HeartWare device as he was if the device remained
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`in his body.
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`V.
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`Marshall seeks damages from Medtronic, under two theories of recovery, namely:
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`(1)
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`Products liability based upon:
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`(a)
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`(b)
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`(c)
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`Manufacturing defect;
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`Design defect; and
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`Marketing defect.
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`(2)
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`Negligence in the marketing and the manufacturing of the HeartWare
`device manufactured and sold by Medtronic, which is the subject of
`this lawsuit; additionally, invoking the negligence doctrine of res psa
`loquitur.
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`VI.
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`When it is alleged that Medtronic committed an act or practice, or by omission failed to act,
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`it is meant that Medtronie acted or failed to act by and through its agents, servants and employees
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`whose acts or omissions were within the scope of their authority or employment.
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`The cause of action giving rise to this lawsuit, that is, the claims for damages for the injuries
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`sustained by the plaintiff as a result of Medtronic's wrongdoing, arose in Harris County, Texas.
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`Medtronic was at the time of this occurrence and was the major designer, manufactorer and
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`marketer of the HeartWare device. Additionally, at all times pertinent hereto, Medtronic was a
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`merchant with respect to the HeartWare device within the meaning of TEX. BUS. & COM. CODE
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`5 2.314. Medtronic was, at all times pertinent hereto, the marketer and seller of the HeartWare
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`device.
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`W".
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`Medtronic's decision to pull the HeartWare device from the market followed a series of
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`Class I recalls, including three in 2021 alone, resulting in reports of 91 injuries and 15 deaths of
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`patients with the implanted device. The Federal Drug Administration (FDA) advised healthcare
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`providers in late May, 2021, to cease new implants of the HeartWare device system, indicating that
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`Medtronic had "received over 100 complaints involving delay or failure to restart of the HeartWare
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`device, including reports of 14 patient deaths and 13 cases where an explant was necessary."
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`Medtronic had acquired the HeartWare device was part of its $1.1 billion acquisition of
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`HeartWare International in 2016. The device was intended to help patients suffering from heart
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`failure pumping blood through their bodies. The system, wbich included an implantable pump and
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`non-implantable components, is a Class III medical device, meaning it constitutes a high risk and
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`can pose a significant risk of injury to patients.
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`Since the HeartWare device received premarket approval in November, 2012, the FDA has
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`issued 13 Class I recalls involving multiple parts and components of the pump.
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`Issues and
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`malfunctions ranged from devices failing to restart to the company needing to update instructions
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`for use and patient manuals. While some recalls predate Medtronic's acquisition, nine Class I recalls
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`have come since Medtronic bought HeartWare.
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`Along with numerous recalls, the HeartWare device has received thousands of reports of
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`patient injuries, deaths and device malfunctions in the FDA's Manufacturer and User Facility Device
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`Experience (MAUDE) database. An analysis of MAUDE data by the watchdog group ECRI
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`showed Medtronic's HeartWare device had a higher rate of device malfunction than comparable
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`devices marketed by rival companies.
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`0:4
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`Marshall's HeartWare device was not intended to be defective and cause unanticipated or
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`unnecessary delays or failures to restart the pumping of blood. Such a defect was not intended to be
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`part of the HVAD pump design or purpose. As a result, Marshall has sustained both physical and
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`mental damages, particularly the mental stress of having an implanted device that is very unreliable
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`and cannot be removed due to the lethal risk of expla.ntation.
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`XI.
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`Medtronic has removed the HeartWare device from the market due to its use being
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`associated with increased risks of mortality. Patients, such as Marshall, who have been implanted
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`with the device have increased morbidity, with anxiety, depression, and even post-traumatic stress
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`response due to the device being implanted in their bodies. These consequences can lead to further
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`fanctional decline in the patient, such as Marshall, and a decreased quality of life.
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`The HeartWare device, as manufactured, designed and marketed by Medtronic, is defective
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`and unsafe.
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`The defect in the manner in which the HeartWare device was designed or manufactured at
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`the time it left the possession of Medtronic rendered the product unreasonably dangerous and made
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`it dangerous to an extent beyond which would be contemplated by the ordinary user of the product,
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`including this plaintiff, with the ordinary knowledge common to the community as to the product's
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`characteristics.
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`There was a design defect caused by Medtronic at the time the HeartWare device left the
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`possession of Medtronic that rendered the product unreasonably dangerous as designed, taking into
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`consideration the utility of the product and the risk involved in its use.
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`The design and manufactu.ring defects in the HeartWare device that are involved in this
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`lawsuit existed in said product while it was in the hands of Medtronic, and such defect rendered said
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`product unfit for the ordinary purposes for which it was to have been used by the ultimate user,
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`including this plaintiff, because of a lack of something necessary for adequacy.
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`There was a defect in the marketing of HeartWare device caused by Medtronic at the time it
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`left the possession of Medtronic in that there was a failure by Medtronic to give adequate warnings
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`of said product's dangers that were known by Medtronic or by the application o£ reasonably
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`developed skill and foresight should have been known by Medtronic, or there was a failure by
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`1Vledtronic to give adequate instructions to avoid such dangers, which failures rendered the
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`HeartWare device unreasonably dangerous as marketed.
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`The foregoing defects, taken together, separately or in combination, constituted a producing
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`or proximate cause or causes of the plaintiffs damages.
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`Marshall did not and in the exercise of reasonable diligence could not have discovered the
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`defects in design, manufacture and/or marketing of the HeartWare device HVAD pump system
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`prior to the date it was implanted in his chest and the resulting injuries he sustained. Neither did he
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`discover nor in the exercise of reasonable diligence could he have discovered the negligence of
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`Medtronic in the design, manufacturing and/or marketing of the HeartWare device prior to the date
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`product was implanted in his chest and the resulting injuries he sustained.
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`~~I
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`Medtronic was negligent in designing, manufacturing and marketing the HeartWare device in
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`question in the following respects:
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`(1)
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`(2)
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`Medtronic was negligent in failing to properly design or compose the
`HeartWare device; and
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`Medtronic was negligent in offering the HeartWare device for sale to the
`general public without warning the end users of the dangers associated with
`the HeartWare device.
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`Marshall cannot more specifically allege the acts and/or omissions of negligence in the
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`manufacturing and/or design of the HeartWare device in question for the reasons that the facts in
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`that regard are peculiarly within the knowledge of Medtronic. In this connection, Marshall would
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`show that the design and manufacturing of the HeartWare device was within the exclusive
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`possession a.nd control of Medtronic. Marshall had no means of ascertaining the method and
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`manner in which the HeartWare device was designed, tested and manufactured. The product was
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`prescribed to and taken as recommended by plaintiff in the same condition it was in when it left the
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`possession and control of Medtronic. The occurrence causing the injury to the plaintiff, as
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`described herein, was one which, in the ordinary course of events, would not have occurred without
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`the negligence on the part of Medtronic in the design and/or manufacturing of the HeartWare
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`device. Thus the plaintiff is entitled to invoke the negligence doctrine of res ipsa loquitur, thereby
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`making Medtronic guilty of negligence in the design, manufacturing and marketing of the HeartWare
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`device without further proof, which negligence was a proximate cause of the injuries and damages
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`sustained by the plaintiff.
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`XV.
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`Marshall's damages exceed the jurisdictional limits of this Court. The plaintiff has been
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`damaged in the following particulars, viz:
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`a.
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`b.
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`C.
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`d.
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`e.
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`f.
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`g.
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`h.
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`i.
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`Loss of wages in the past and future;
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`Reasonable and necessary costs of inedical care and treatment including
`doctors, hospitals, nurses, medicine, and other services and supplies in the
`past;
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`Reasonable and necessary costs of inedical care and treatment including
`doctors, hospitals, nurses, medicine, and other services and supplies that in
`all reasonable probability plaintiff will suffer in the future;
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`Physical pain suffered by the plaintiff in the past;
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`Physical pain which the plaintiff will in all reasonable probability suffer in the
`future;
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`Mental anguish suffered by the plaintiff in the past;
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`Mental anguish which the plaintiff will in all reasonable probability suffer in
`the future;
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`Past impairment suffered by the plaintiff;
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`Future impairment that will be suffered by the plaintiff in all reasonably
`probability;
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`Past disfigurement suffered by the plaintiff; and
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`k.
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`Future disfigarement that will be suffered by the plaintiff.
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`As a result of such particulars, Marshall has been damaged in an amount in excess of the minimum
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`jurisdictional limits of this Court.
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`Marshall is entitled to recover his actual damages, prejudgment interest, and exemplary or
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`punitive damages as a result of the above allegations of liability and damages. The assessment of any
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`exemplary and/or punitive damages should include evidence of and consideration of reasonable
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`attorney's fees.
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`WHEREFORE, PREMISES CONSIDERED, Ricky Marshall, plaintiff, requests Medtronic,
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`Inc., defendant, be cited to appear and a.nswer, and that upon final trial, they have:
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`a.
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`b.
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`C.
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`d.
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`Judgment against Medtronic Inc. for ONE MILLION AND NO/100
`DOLLARS ($1,000,000.00);
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`Pre-judgment and post-judgment interest on damages assessed against the
`defendant at the prescribed legal rate;
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`Costs of court; and
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`Such other and further relief, at law or in equity, to which they may be justly
`entitled.
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`Respectfully submitted,
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`THE TRIMBLE FIRM, P.L.L.C.
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`/Q/ DaQe Z. ?ZuscZee
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`By
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`Dale L. Trimble
`State Bar No. 20222650
`209 Simonton Street
`Conroe, Texas 77301
`Telephone:
`(936) 441-3456
`(936) 539-3457
`(936) 539-3464
`Telecopier:
`Email: eservice(a7trimblefirm.com
`Counsel for Plaintiff, Ricky Marshall
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`-8-
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